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Found 3 results
510(k) Data Aggregation
K Number
K001986Device Name
SURGITRON IEC IIManufacturer
Date Cleared
2000-09-27
(90 days)
Product Code
Regulation Number
878.4400Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SURGITRON IEC II
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K001407Device Name
SURGITRON IEC IIManufacturer
Date Cleared
2000-07-24
(81 days)
Product Code
Regulation Number
878.4400Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SURGITRON IEC II
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K001253Device Name
SURGITRON IEC IIManufacturer
Date Cleared
2000-05-26
(37 days)
Product Code
Regulation Number
878.4400Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SURGITRON IEC II
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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